Nintedanib Stada (Nintedanib)

Nintedanib is indicated for fibrotic lung diseases, where it targets pathways that lead to progressive scarring.

• Idiopathic pulmonary fibrosis: slows disease progression and preserves lung function.
• Systemic sclerosis‑associated interstitial lung disease: reduces decline in forced vital capacity and improves quality of life.
• Progressive fibrosing interstitial lung disease: attenuates loss of lung capacity in patients with other fibrotic ILDs.

• Nintedanib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR 1‑3), fibroblast growth factor receptors (FGFR 1‑3) and platelet‑derived growth factor receptors (PDGFR α/β). By blocking these pathways, the drug reduces fibroblast proliferation, angiogenesis, and extracellular matrix production, which are central processes in the development of pulmonary fibrosis and related fibrotic disorders.

Nintedanib may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

• Diarrhea: frequent loose stools, often mild to moderate.
• Nausea: feeling of unease or urge to vomit.
• Vomiting: occasional expulsion of stomach contents.
• Decreased appetite: reduced desire to eat.

Serious or Rare Side Effects

• Liver injury: elevated transaminases or hepatitis.
• Bleeding events: gastrointestinal or other hemorrhage.
• Gastrointestinal perforation: rare but potentially life‑threatening.
• Severe hypersensitivity: rash, angioedema, or anaphylaxis.

Before initiating therapy, clinicians should consider several safety measures.

• Liver function monitoring: perform baseline and periodic liver enzyme tests.
• Bleeding risk assessment: avoid in patients with active bleeding or uncontrolled anticoagulation.
• Cardiovascular evaluation: monitor for hypertension or ischemic events.
• Renal impairment: adjust use in severe renal dysfunction.
• Pregnancy and lactation: use only if benefits outweigh potential risks.
• Store at below 25°C: keep in the original pack, protect from moisture.

Nintedanib can interact with other medicines, requiring attention to the level of risk.

Major Interactions (Avoid)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase nintedanib exposure.
• Anticoagulants (e.g., warfarin, direct oral anticoagulants): heightened bleeding risk.
• High‑dose aspirin or NSAIDs: increased gastrointestinal bleeding.

Moderate Interactions (Monitor Closely)

• CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce efficacy.
• P‑gp inhibitors (e.g., verapamil): modestly raise plasma levels.
• Diuretics (e.g., furosemide): may affect renal clearance.